Exemption from authorisation for medicines for small pet animals

Certain medicines for small pet animals are exempt from the marketing authorisation requirements of the Veterinary Medicines Regulations (VMR), as amended, under Schedule 6.

Registration

FromAll 17 November 2024, all companies or persons who intend to place a product on the GB market must register with the Veterinary Medicines Directorate (VMD), on behalf of Secretary of StateState, at least 2 months before marketing the product.

To register your company and/or new productsproducts, pleaseyou must complete the new online form. ApplicationThis forreplaces registrationthe ofprevious products (PDF, 272form KB,and 11allows pages)you andto sendinclude up to schedule_6_registrations@vmd.gov.uk

On25 anproducts annualper basis,submission. companiesIf you need to add more than this, you will need to submit a second form.

Companies or persons placing products on the market must also submit an annual return/registration.return by Further17 guidanceNovember onof howeach toyear. registerThe andreturn must include all products marketed even if previously registered. You can submit anyour annual return afterby 17completing Novemberthe 2024online form.

You will receive notification of the outcome of your registration or annual return by email.

When completing the online form, you will need the following information to hand:

1. Name and address of the company marketing the product
2. Name, email address and phone number of the contact person marketing the product
3. Country, name, email address and phone number of the company manufacturing the product (if different to 2.)
4. Name of the marketed product(s)
5. Route of administration, dosage form, indicated species, active substance(s), the amount of the active substance(s) per unit
6. Dosing instructions

If you have any questions specifically relating to registration, please contact:contact: schedule_6_registrations@vmd.gov.uk.

Notification of changes

You must notify the VMD if any of the registered information has changed.

Tell us by completing the form and selecting the ‘Changed registration’ option when prompted to provide product details.

If a registered product is no longer marketed, you must notify the VMD by emailing schedule_6_registrations@vmd.gov.uk.

Exempt species

Medicines for the following species are exempt provided the animals are kept exclusively as pets and are not intended to produce food for human consumption:

• aquarium animals, including fish only kept in closed water systems
• cage birds; birds kept in cages or aviaries
• homing pigeons; pigeons kept for racing or exhibition
• terrarium animals; reptiles, amphibians and arthropods kept in tanks and cages, including animals free-living in domestic gardens
• small rodents; domestic mammals of the order rodentia
• ferrets
• rabbits

Chickens, ducks and turkeys are classified as food producing animals and so medicines for these species are not, under any circumstances, covered by the exemption.

Active substances

Exempt medicines can only contain active substances which have been approved for the purposes of this exemption by the Secretary of State. Approval may not be granted if the active substance requires veterinary control, see section ‘Medicines not included in the exemption’.

Schedule 6 Table of approved active substances (PDF, 840 KB, 20 pages)

If you wish to market a product under the exemption which contains a substance not included on this list or for an exempt species or route of administration not currently included for a substance on the list, you must apply using the Application for active approval form (PDF, 86.9 KB, 4 pages).

Your completed application form should be sent to pet.exemptions@vmd.gov.uk.

Do not submit any studies or reports unless specifically requested. A brief justification for inclusion of the active substance will usually be sufficient.

Under the exemption, combinations of active substances may be marketed within the same product, provided each individual substance is included on the list of approved active substances.

Medicines not included in the exemption

The following medicines are not covered by this exemption:

• antibiotics
• narcotic or psychotropic substances*
• those intended for treatments or pathological processes that require a precise diagnosis by a vet or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures

*Certain sedatives may be permitted for use with fish. Please contact us for further information.

Purpose of use and route of administration

Exempt medicines are restricted to topical or oral administration routes only:

• Topical medicines are those that are applied externally to the skin and have a local or systemic action. This excludes products that are administered in the eye or ear canal, intra-nasally or via nebulisation; aerosol delivered to the airways and lungs.

• Oral medicines are defined as those that are administered in feed, in water or directly into the oral cavity.
  This excludes products that are administered by stomach or crop tubing; gavage.

Fish medicines administered via the water and not intended for direct ophthalmic use are acceptable.

Labelling requirements

Exempt products must be clearly labelled to show that they are exempt from having a marketing authorisation, for example by including the following statement on the outer packaging:

The labelling must contain the following information either on the label or, if there is insufficient space, on a package leaflet:

• name of the product
• the authorisation number of the manufacturer*
• name and strength of each active substance
• route of administration
• batch number
• expiry date
• the words, For animal treatment only
• contents by weight, volume, or the number of unit doses
• name and address of the manufacturer or distributor
• target species
• the words, Keep out of reach of children
• storage instructions
• the shelf life after the immediate packaging has been opened for the first time
• disposal advice
• full indications, including:
  • therapeutic indications
  • contra-indications
  • interaction with other medicines and other forms of interaction
• dosage instructions

*If no suitable manufacturing authorisation number is issued by the relevant National Competent Authority, we can issue one.

If you apply for an authorisation number you should provide evidence to demonstrate that the manufacture of the product is in accordance with Good Manufacturing Practice (GMP). Further guidance on manufacturing is below.

The label on the product itself must contain at least the following:

• name of the product
• name and strength of each active substance
• route of administration
• batch number
• expiry date
• the words, For animal treatment only
• any additional warnings that are required may be stipulated for the particular active substance. These can be found on the list of approved active substances

Pack sizes

Exempt products must only be sold in pack sizes suitable for a single course of treatment. The VMD considers this condition should be met by ensuring that packs contain only sufficient product to treat the following numbers of animals until symptoms are alleviated or, for preventative treatments, up to six months:

Species	Pack size
Aquarium animals	a single course of treatment should be no more than 7 administrations to an aquarium of up to 25,000 litres. The course of treatment should be clearly defined, for example, Administer to aquarium for 7 consecutive days.
Cage birds	to treat no more than 50 birds
Homing pigeons	to treat no more than 50 birds
Terrarium animals	to treat no more than 5 animals
Small rodents	to treat no more than 5 animals
Ferrets	to treat no more than 5 animals
Rabbits	to treat no more than 5 animals

Manufacturing and supply

Exempt medicines must meet the requirements of the VMR relating to the manufacture (GMP) and wholesale dealing of veterinary medicines.

For further information about how to obtain a manufacturing authorisation, refer to Manufacturing Authorisations for veterinary medicines.

Veterinary medicines marketed under this exemption must be manufactured by the holder of a manufacturing authorisation issued under:

• a certificate issued by the VMD on behalf of the Secretary of State (sites in the UK and all other countries)
• a certificate issued by the competent authority of one of the following countries: the EU, Australia, Canada, New Zealand, Switzerland and the USA

There are no restrictions on the retail supply within the UK of products manufactured under the exemption but they may only be wholesale supplied by the holder of a Wholesale Dealer Authorisation (WDA).

Wholesale dealers supplying products under the exemption are not required to keep wholesale records that duplicate manufacturer’s records.

For information on how to obtain a WDA go to Veterinary medicine wholesale dealer’s authorisation.

There are no restrictions on the importation of products which fully comply with this exemption.

Pharmacovigilance

Manufacturers and importers must report any serious adverse event to uus within 15 days of becoming aware of it; and must keep records of all adverse events for 3 years, which they must make available to us on request. For details on how to report adverse events refer to Report a suspected problem with an animal medicine or microchip.

For further information refer to the Pharmacovigilance of Veterinary Medicines in Great Britain.

Preventing illegal use

When marketing an exempt medicine you must take reasonable measures to prevent its illegal use in animal species not covered by the exemption. For example, you must ensure that any advertising does not falsely describe the product or mislead as to its nature, quality, uses or effect.

Exempt products and the prescribing cascade

As exempt products are not authorised medicines they do not fall under the prescribing cascade. If vets wish to use one of these products not in accordance with its recommended use, this would be classed as use under the cascade and considered an extemporaneous preparation.

For more information refer to The Cascade: Prescribing unauthorised medicines guidance.

Contact

For furtherqueries information and to be included on ourproduct mailingregistration, listemail  forschedule_6_registrations@vmd.gov.uk

For updatesqueries abouton theactive exemption,substance registration, email pet.exemptions@vmd.gov.uk.